Drugs agency news

[Guest guest]

Posted by Menzies-Trull Herbalist and Documentary film-maker.

Dear Herbalists,

Report from the 'I Newspaper' [independent] Wednesday 11th May 2011

Drugs agency 'put business interests ahead of safety'.

By Lawrence Health Editor.

The body that licences medicines in Europe is today accused of putting

commercial interests ahead of the safety of patients after two scientsits

battled for three years to get access to unpublished trial data. The European

Medicines Agency [ EMA] only released the trial findings in February after the

European Ombudsman ruled that it was guilty of maladministration.

Pharmaceutical companies invest millions of pounds in research and have a

powerful interest in publishing positive findings while keeping quiet about

those trials which show no effect. This is known as 'publication bias' - the

selection of positive studies for publication.

Publication bias has been blamed for the debacle over the powerful painkiller

Vioxx, which was withdrawn from the market in 2004 over fears that it could

cause heart attacks. Professor peter Gotzsche and Anders nsen from the

Nordic Cochrane Centre in Denmark said Vioxx 'has presumably caused about

100.000 unecessary heart attacks in the USA alone' as a result of selective

reporting.

They decided to investigate two obesity drugs, Orlistat and Silbutramine and

requested tha unpublished trial data from the EMA in June 2007. But the EMA

refused access, citing commercial confidentiality. In June 2010 the European

Ombudsman, Nikoforos Diamandouros, criticised the EMA. The EMA responded in

November, saying it would widen public access to trial reports but did not

release the data on the obesity pills to the researchers until 1st February

2011.

Writing in the British Medical Journal, the scientists said: 'There is something

fundamentally wrong with our priorities if commercial success depends on

withholding data that are important for decision making by doctors and

patients'. The EMA said yesterday it had released 129,303 pages of documents to

the Cochrane researchers.

End